510(k) Report

Devices descending from K952681

1,700 later devices reach Stryker Hummer II Microdebrider System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+12K213184MZ Skin LightMAX Supercharged LED Mask 2.0Mz Skin202135—
+12K210350Gemini 2 810+980 Soft Tissue LaserAzena Medical, LLC20211—
+12K212331BodySculpRohrer Aesthetics, LLC20211—
+12K201773PicohiHironic Co., Ltd.20215—
+12K211402Powersculp laser lipolysis systemLotuxs Medtech (Suzhou) Co., Ltd.20210—
+12K211821DEKA Motus AZEl.En Electronic Engineering Spa20211—
+12K210549ARx Spinal SystemLife Spine, Inc.20211—
+12K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+12K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—
+12K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+12K201731Diode Laser Body Sculpture SystemShanghai Apolo Medical Technology Co., Ltd.20201—
+12K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+12K173677InMode VLazeInmode MD, Ltd.20183—
+12K172771Epic Pro 940Biolase, Inc.20171—
+12K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+12K171111SculpsureCynosure, Inc.201710—
+12K163222Discovery Pico FamilyQuanta System Spa201630—
+12K162050ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201614—
+12K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—
+12K152434XprESS Multi-Sinus Dilation SystemEntellus Medical, Inc.201511—
+13K261851LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED…Shenzhen Qianyu Technology Co., Ltd.20260—
+13K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+13K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+13K260138LUNE PureHygieneEnamel Pure20260—
+13K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+13K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+13K260765Gemini NOVA 810+980 Soft Tissue LaserAzena Medical, LLC20260—
+13K253829Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+13K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda20260—
+13K252745Halo Sterile Single-use Radial Fiber…Micro-Energy Medical Technology Co., Ltd.20251—
+13K253007Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber…Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.20250—
+13K252447Picosecond laser device (BMPS4)Hebei Newangie Technology Co., Ltd.20250—
+13K252096Light Therapy Decollete Mask (1019135)Merchsource, LLC20250—
+13K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+13K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+13K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+13K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+13K250966CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+13K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+13K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE…Gigaalaser Company, Ltd.20251—
+13K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+13K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+13K242068LED Light Therapy Mask (RT01)Ningbo Dechang Electrical Machinery Made Co.,Ltd20250—
+13K250113neoLaser Laser Surgery FibersG.N.S Neolaser, Ltd.20250—
+13K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+13K242941CO2 Laser Therapy Systems (SHE-LSP003-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+13K243040LED Light Therapy Mask…Shenzhen Siken 3D Technology Development Co., Ltd.20241—
+13K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+13K241144Picosecond Nd:YAG Laser (PICOCAREMAJESTY)Wontech Co., Ltd.20241—
+13K241459MOTUS PRO FamilyEl.En S.P.A.20240—
+13K233007Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc.20241—
+13K240752Deka ToroEl.En S.P.A.20240—
+13K2406581060nm laser body slimming machineHebei JT Medical Co., Ltd.20240—
+13K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+13K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+13K234104PICOANDY (Q-Switched Nd:YAG Laser)Wontech Co., Ltd.20242—
+13K233114LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200)Shenzhen Idea Light Limited20241—
+13K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd.20232—
+13K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+13K230467BTL-899FBTL Industries, Inc.20231—
+13K230258BB 8 Sinus Dilation KitExcelent, Inc.20230—
+13K222226EONDominion Aesthetic Technologies, Inc.20230—
+13K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+13K214103Shani Darden LED light therapy maskHarpar Grace International202219—
+13K212573PicoLO PremiumLaseroptek Co., Ltd.20210—
+13K192970SlimusHironic Co., Ltd.20200—
+13K171992SculpSureCynosure, Inc.20178—
+13K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+13K171069ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.20178—
+13K163509XprESS ENT Dilation SystemEntellus Medical, Inc.20179—
+14K261701Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)Micro-Energy Medical Technology Co., Ltd.20260—
+14K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight…Wuhan PHOMED Technology Company, Ltd.20260—
+14K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—
+14K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+14K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+14K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+14K231971Deka Physiq 360El.En S.P.A.20230—
+14K230124LUSTRE ClearSkin Renew Pro Facewear Mask (Model: PR4001)Light Tree Ventures Europe B.V.202310—
+14K220027Audion ET dilation systemEntellus Medical, Inc.20220—
+14K210841NuVent Eustachian Tube Dilation BalloonMedtronic Xomed, Inc.20210—
+14K201398SINUSPRIME Dilation SystemStryker Ent20200—
+14K182741SculpSureCynosure20195—
+14K171761ACCLARENT AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc.20185—
+14K172144CoolSculpting SystemZeltiq Aesthetics20177—
+14K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+15K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+15K230742ACCLARENT AERA Eustachian Tube Dilation SystemAcclarent, Inc.20231—
+15K223542TubaVent Balloon Dilatation SystemSpiggle & Theis Medizintechnik GmbH20230—
+15K231131Diode Laser Body Sculpture SystemsShanghai Bele Medical Technology Co.,Ltd20230—
+15K213889PicoStarAsclepion Laser Technologies GmbH20220—
+15K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+15K181740ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201805
+16K253612Acclarent AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc.20260—
+16K202503ChromeQuanta System Spa202012—
+17K253765Vanish ProDdc Technologies, Inc.20260—
+17K241527Pastelle ProWontech Co., Ltd.20253—
+17K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa20230—
+17K213726PL-1 Skin Treatment SystemAVAVA, Inc.20220—
+17K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+18K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—